FDA-filed SPL labeling · retrieved through openFDA

Bempedoic Acid

Bempedoic acid is a cholesterol-lowering medicine used to reduce LDL ('bad') cholesterol in adults with high cholesterol and to lower the risk of serious heart and blood vessel events in adults who cannot take recommended statin therapy.

Brand name Nexletol
Drug class Adenosine Triphosphate-citrate Lyase Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 25, 2026
AvailabilityRx
Earliest approval/marketing year 2019
FDA-listed product records 15
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Bempedoic Acid at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Bempedoic acid (Nexletol) is a once-daily tablet that lowers LDL cholesterol and reduces the risk of heart attack and stroke in adults who can't tolerate standard statin doses. It's generally well tolerated, but watch for tendon pain and signs of gout, and tell your doctor right away if either develops. It should be avoided during pregnancy and is not approved for use in children.

📖 Bempedoic Acid: Patient Information Guide

A plain-language walkthrough of Bempedoic Acid — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Bempedoic acid (available as Nexletol) is approved for two related uses in adults:

  • Cardiovascular risk reduction: Nexletol reduces the risk of major cardiovascular events — cardiovascular death, heart attack, stroke, and procedures to open blocked arteries — in adults at increased risk for these events who are unable to take recommended statin therapy, including those not currently on a statin.
  • Lowering LDL cholesterol: Nexletol is used with diet and exercise to reduce LDL cholesterol in adults with high cholesterol (hypercholesterolemia), including heterozygous familial hypercholesterolemia (HeFH). It can be combined with other cholesterol-lowering therapies or used alone when combining is not possible.
⚙️How it works

Bempedoic acid blocks an enzyme in the liver called ATP-citrate lyase (ACL), which sits early in the pathway the body uses to make cholesterol. Blocking ACL causes the liver to produce less cholesterol — and in response, the liver increases the number of LDL receptors on its surface, pulling more LDL cholesterol out of the blood. Because the enzyme it targets is found mainly in liver cells (not muscle cells), it works differently from statins.

Once absorbed, bempedoic acid must be activated inside liver cells by another enzyme (ACSVL1) that is expressed primarily in the liver. This liver-specific activation is one reason muscle-related side effects seen with statins are less prominent with bempedoic acid.

💊How it's taken

Nexletol comes as an oral tablet taken once daily. It can be taken with or without food — whichever is easiest to stick to. Steady cholesterol-lowering levels in the body are typically reached within about one week of starting. Your doctor will usually recheck your cholesterol 8 to 12 weeks after you begin to see how well it's working. Always follow your prescriber's instructions for your specific dose and schedule.

🤒Side effects — in detail

Most people tolerate Nexletol well, but some side effects can occur. The most commonly reported ones include:

  • Upper respiratory tract infections (colds, nasal congestion)
  • Muscle spasms
  • High uric acid levels (hyperuricemia), which can lead to gout
  • Back pain
  • Abdominal pain or discomfort
  • Bronchitis
  • Pain in the arms or legs
  • Anemia (low red blood cell levels)
  • Elevated liver enzymes

More serious reactions — including tendon rupture, severe allergic reactions (angioedema), and significant rises in uric acid leading to gout — require prompt medical attention. Stop taking Nexletol and call your doctor or seek emergency care if any of these occur.

⚠️Warnings & precautions
  • Tendon rupture: Nexletol increases the risk of tendons tearing — particularly in the shoulder (rotator cuff), biceps, and Achilles tendon. This can happen within weeks to months of starting. Stop taking it immediately at the first sign of tendon pain or rupture. People over 60, those on corticosteroids or fluoroquinolone antibiotics, and those with kidney failure or prior tendon problems are at the highest risk.
  • High uric acid and gout: Nexletol raises blood uric acid levels. This usually begins within the first four weeks, persists during treatment, and returns to normal after stopping. High uric acid can trigger gout — a very painful joint condition. Tell your doctor if you notice joint redness, swelling, or sudden severe pain.
  • Serious allergic reactions: Rare but serious hypersensitivity reactions — including angioedema (deep swelling of the face or throat), wheezing, rash, and hives — have been reported after approval. Nexletol is contraindicated in anyone who has previously had a serious allergic reaction to it.
  • Lab changes to watch for: Nexletol can cause small rises in creatinine and blood urea nitrogen (kidney markers), small drops in hemoglobin (red blood cell protein), and rises in liver enzymes. Your doctor may monitor these periodically.
🔀What it interacts with

Nexletol has a few important drug interactions to be aware of:

  • Simvastatin (above 20 mg): Nexletol raises simvastatin blood levels, which can increase the risk of muscle injury (myopathy). Avoid combining Nexletol with simvastatin doses above 20 mg.
  • Pravastatin (above 40 mg): Nexletol raises pravastatin levels and can increase the risk of muscle problems. Avoid doses above 40 mg when taken together.
  • Fibrates (cholesterol drugs like fenofibrate or gemfibrozil): Combining with Nexletol has been associated with increased triglycerides and decreased HDL ('good') cholesterol in some patients. Your doctor should check these levels about four weeks after starting both medicines and periodically after that.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take Nexletol if you have previously had a serious allergic reaction (including angioedema) to bempedoic acid or any of its ingredients.
  • Tell your doctor about any history of tendon problems or tendon rupture — Nexletol may not be right for you.
  • If you are pregnant or planning to become pregnant, talk to your doctor. Nexletol may harm a developing fetus because of how it affects cholesterol synthesis. It should be stopped when pregnancy is confirmed unless the benefits clearly outweigh the risks.
  • Bempedoic acid passes into breast milk. Discuss the risks and benefits with your doctor before breastfeeding while on Nexletol.
  • Nexletol has not been studied in children and is not approved for pediatric use.
  • Adults 60 and older face a higher risk of tendon rupture on Nexletol, especially if also taking steroids or fluoroquinolone antibiotics.
  • No dose adjustment is needed for mild or moderate liver impairment (Child-Pugh A or B). Nexletol has not been studied in severe liver impairment (Child-Pugh C).
  • No dose adjustment is needed for mild, moderate, or severe kidney impairment or kidney failure based on available data.
🚑If you take too much

There is no clinical experience with Nexletol overdose. If you or someone else may have taken too much, contact the Poison Help line at 1-800-222-1222 or seek emergency medical care right away. A medical toxicologist can provide additional guidance.

📡Pharmacodynamics — effects in the body

Bempedoic acid lowers LDL cholesterol, non-HDL cholesterol, apolipoprotein B (a protein that carries bad cholesterol), and total cholesterol — whether used alone or combined with other lipid-lowering medicines. At doses higher than the standard daily dose, it does not have a clinically meaningful effect on the heart's electrical rhythm (QT interval), meaning it does not appear to raise the risk of abnormal heart rhythms through that mechanism.

🔬Pharmacokinetics — how your body processes it

After taking a Nexletol tablet, bempedoic acid is absorbed and reaches peak blood levels in about 3.5 hours. Food does not meaningfully affect how much is absorbed, so it can be taken with or without a meal. The drug has a half-life of about 21 hours, and steady levels in the body build up over approximately 7 days of once-daily dosing. Bempedoic acid is broken down mainly in the liver and eliminated primarily through the urine (about 70%) and feces (about 30%), mostly as metabolites rather than as unchanged drug.

📦How to store it

Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) . Store and dispense in the original package.

📄 Written from Bempedoic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

21

Supplements & herbs that interact with Bempedoic Acid

21 supplements and herbal products have documented interactions with Bempedoic Acid in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 11
  • Minor · 9
Every supplement checked against Bempedoic Acid — ranked by severity The full interaction hub: 1 major · 11 moderate · 9 minor · every one linked to its full report. Check Bempedoic Acid against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Bempedoic Acid — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Nexletol supposed to do for me?
Nexletol does two things depending on why your doctor prescribed it. If you're at higher risk for heart disease and can't tolerate statins, it helps lower the chance of a serious event like a heart attack or stroke. It can also lower your LDL — the 'bad' cholesterol — as part of a broader plan that includes diet, exercise, and possibly other cholesterol medicines. It's not a substitute for healthy habits, but it's a real, evidence-backed tool on top of them.
Can I take Nexletol if statins made my muscles hurt?
Nexletol was specifically developed for people who can't tolerate recommended statin doses, so that situation is exactly what it's designed for. It works differently from statins and acts mainly in the liver rather than in muscle tissue. That said, muscle spasms are still reported as a side effect, so let your doctor know if you notice any new muscle issues after starting it.
Do I need to take it with food?
No — food doesn't change how well Nexletol is absorbed, so you can take it with or without a meal. Once a day at a time that's easy for you to remember is all that's needed. Staying consistent with your timing helps keep your levels steady.
I heard it can cause gout — should I be worried?
It's a real risk worth knowing about. Nexletol can raise uric acid levels in the blood, and high uric acid can trigger gout — a sudden, very painful swelling usually in a joint like your big toe, ankle, or knee. The uric acid increase usually happens in the first few weeks. Your doctor may check your uric acid level periodically, and if gout develops, it can be treated. If you notice sudden severe joint pain or swelling, call your doctor promptly.
What tendon warning should I really pay attention to?
Nexletol is associated with a small but real risk of tendon rupture — the tendon can actually tear, most often in the shoulder, biceps, or Achilles (back of the ankle). If you feel sudden sharp pain, hear a 'pop,' or notice swelling in a tendon area, stop taking the medicine and contact your doctor right away. This risk is higher if you're over 60, taking certain antibiotics (fluoroquinolones) or steroids, or have had tendon problems before.
Is it safe if I'm pregnant or trying to get pregnant?
Nexletol should generally be stopped as soon as you find out you're pregnant, because it affects cholesterol synthesis in a way that could potentially harm the developing baby. Cholesterol management can usually wait during pregnancy without major long-term consequences, so most doctors will pause this type of medication. If you're planning to get pregnant, talk to your doctor ahead of time so you can plan together. Bempedoic acid also passes into breast milk, so breastfeeding while on it requires a careful conversation with your doctor.
Is Bempedoic Acid available over the counter?
Bempedoic Acid is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Bempedoic Acid first available?
Bempedoic Acid has been available in the United States since at least 2019, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Bempedoic Acid?
Bempedoic Acid is supplied by 12 manufacturers listed in the FDA NDC Directory, including Esperion Therapeutics, Inc., APICHEM Laboratories Private Limited, Aurobindo Pharma Limited.

💬 Answers drafted from Bempedoic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Bempedoic Acid comes

Bempedoic Acid is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Nexletol
How this form is used
What it may be used for
  • Nexletol is used to reduce the risk of cardiovascular death, heart attack, stroke, and coronary artery procedures in adults at increased risk who cannot take recommended statin therapy
  • Nexletol is used alongside diet and exercise to lower LDL cholesterol in adults with high cholesterol (hypercholesterolemia), including heterozygous familial hypercholesterolemia (HeFH)
Important instructions
  • Nexletol is taken by mouth once daily
  • Nexletol can be taken with or without food
  • After starting Nexletol, your doctor will typically check cholesterol levels within 8 to 12 weeks
  • Follow your prescriber's instructions for the exact dose and schedule
Available strengths 1 strength
5 FDA-listed product records

📊 Bempedoic Acid across the U.S. market

How Bempedoic Acid appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
12
Manufacturers
1
Brand names
15
FDA-listed product records
2019
First marketed

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Esperion Therapeutics, Inc.27%
APICHEM Laboratories Private Limited7%
Aurobindo Pharma Limited7%
Biophore India Pharmaceuticals Pvt. Ltd7%
Corden Pharma Colorado, Inc.7%
Dr. Reddys Laboratories Limited7%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Bempedoic Acid is used

A general measure of how commonly Bempedoic Acid is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Bempedoic Acid is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

11,416
Medicaid prescriptions filled (Q1–Q4 2025)
$6.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bempedoic Acid prescribed? Of the 1,596 medications we measure, Bempedoic Acid ranks #905 by Medicaid prescriptions — more than 43% of them.

Where Bempedoic Acid ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Bempedoic Acid product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

bempedoic acid 180 MG Oral Tablet

11,416 Medicaid prescriptions (Q1–Q4 2025) 100% of Bempedoic Acid prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $551 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2282408

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bempedoic Acid, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Bempedoic Acid NDCs with Medicaid activity.

🔍 Compare Bempedoic Acid products

A representative set of FDA-listed product records for Bempedoic Acid — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Tablet
180 mg Oral Esperion Therapeutics, Inc. × 4 listings NDA View NDC →
180 mg Piramal Healthcare UK Limited DRUG FOR FURTHER PROCESSING View NDC →
💊Bulk drug substance
1 kg/kg APICHEM Laboratories Private Limited BULK INGREDIENT View NDC →
50 kg/50 kg Aurobindo Pharma Limited BULK INGREDIENT View NDC →
50 kg/50 kg Biophore India Pharmaceuticals Pvt. Ltd BULK INGREDIENT View NDC →
1 kg/kg Corden Pharma Colorado, Inc. BULK INGREDIENT View NDC →
1 kg/kg Dr. Reddys Laboratories Limited BULK INGREDIENT View NDC →
1 kg/kg Fareva La Vallee BULK INGREDIENT View NDC →
20 kg/20 kg Metrochem API Private Limited BULK INGREDIENT View NDC →
1 kg/kg Neuland Laboratories Limited BULK INGREDIENT View NDC →
1 kg/kg Optimus Drugs Private Limited BULK INGREDIENT View NDC →
1 kg/kg Pure And Cure Healthcare Private Limited BULK INGREDIENT View NDC →

Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Bempedoic Acid NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Bempedoic Acid RxCUI 2282403 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 2282407 In current FDA listings
    Clinical drug / strength (SCD) 180 MG RxCUI 2282408

Look up RxCUI 2282403 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Nexletol

🏭 Manufacturers & labelers

Esperion Therapeutics, Inc. 4 APICHEM Laboratories Private Limited 1 Aurobindo Pharma Limited 1 Biophore India Pharmaceuticals Pvt. Ltd 1 Corden Pharma Colorado, Inc. 1 Dr. Reddys Laboratories Limited 1 Fareva La Vallee 1 Metrochem API Private Limited 1 Neuland Laboratories Limited 1 Optimus Drugs Private Limited 1 Piramal Healthcare UK Limited 1 Pure And Cure Healthcare Private Limited 1

RxNorm drug class

Bempedoic Acid belongs to the Adenosine Triphosphate-Citrate Lyase Inhibitor class.

Pharmacologic class Adenosine Triphosphate-Citrate Lyase Inhibitor
Drug family (ATC) Other lipid modifying agents
How it works Adenosine Triphosphate-Citrate Lyase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 25, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bempedoic Acid.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Bempedoic Acid after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
15
Distinct labelers/manufacturers represented
12
Linked representative label
Esperion Therapeutics, Inc.
Linked label effective
Jun 25, 2026
Composite sections available
22
Linked SPL Set ID
88d06d89-a3da-40b4-b273-8f4f7d56c4c9
Linked SPL Document ID
e67aa4eb-b86f-4cc0-8a38-e8405de2a113
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Esperion Therapeutics, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.